ABSTRACT
On the other hand, scale-up studies involving relatively low scale-up ratios and few changes in process variables are not necessarily a reasonable alternative to fullscale testing. For that matter, experimental designs employing minor, incremental changes in processing equipment and conditions are unacceptable as well. These alternative test modes are inherently unacceptable as they consume time, an irreplaceable resource [2] that must be used to its maximum advantage. Appropriate process development, by reducing costs and accelerating lead times, plays an important role in product development performance. In The Development Factory: Unlocking the Potential of Process Innovation, author Gary Pisano [48] argues that while Pharmaceuticals compete largely on the basis of product innovation, there is a hidden leverage in process development and manufacturing competence that provides more degrees of freedom in developing products to more adroit organizations than to their less adept competitors. Although Pisano focuses on drug synthesis and biotechnology process scale-up, his conclusions translate effectively to the manufacturing processes for drug dosage forms and delivery systems. In effect, scale-up issues need to be addressed jointly by pharmaceutical engineers and formulators as soon as a dosage form or delivery system appears to be commercially viable. Scale-up studies should not be relegated to the final stages of product development, whether initiated at the behest of FDA (to meet regulatory requirements) or marketing and sales divisions (to meet marketing directives or sales quotas). The worst scenario would entail the delay of scale-up studies until after commercial distribution (to accommodate unexpected market demands).
